Zhen Su, Marengo Therapeutics CEO

Ipsen jumps in­to the TCR space, team­ing with start­up helmed by for­mer Mer­ck KGaA can­cer chief

Ipsen is con­tin­u­ing its deal­mak­ing ways to kick off the new month, shelling out a hand­some $45 mil­lion up­front to a TCR up­start Mon­day morn­ing.

The French phar­ma com­pa­ny is part­ner­ing with Maren­go Ther­a­peu­tics on two ex­per­i­men­tal drugs, with the biotech tak­ing on pre­clin­i­cal work and Ipsen plan­ning to run the clin­i­cal stud­ies. And the pay­off for Maren­go could be huge — Ipsen is promis­ing near­ly $1.6 bil­lion in mile­stones if both pro­grams hit all of their goals.

Mon­day’s part­ner­ship is Ipsen’s first fol­low­ing its $247 mil­lion Epizyme buy­out at the end of June and con­tin­ues a deal­mak­ing spree dat­ing back a lit­tle over a year. The com­pa­ny has en­gaged in all sorts of deals in that time, in­clud­ing with IR­LAB on a dis­ease re­lat­ed to Parkin­son’s, BAKX Ther­a­peu­tics in can­cer and Ex­i­cure for Hunt­ing­ton’s.

Ipsen al­so put down $136 mil­lion up­front last De­cem­ber to part­ner with Gen­fit in NASH, in one of its big­ger re­cent deals.

As it con­tin­ues hunt­ing its next big R&D prize, Ipsen is aim­ing to move past the $1.3 bil­lion Clemen­tia buy­out that sput­tered af­ter its main drug was hit with a fu­til­i­ty fail­ure. In or­der to fund its wheel­ing and deal­ing go­ing for­ward, Ipsen spun out its con­sumer di­vi­sion this past Feb­ru­ary for $460 mil­lion, and the Maren­go deal is the lat­est in that ef­fort.

Maren­go, mean­while, has been fo­cused on ad­vanc­ing its bis­pe­cif­ic an­ti­body plat­form tar­get­ing a spot on T cell re­cep­tors known as vari­able β chains and their vari­ants. It’s an ap­proach ex­ecs hope will help them set the com­pa­ny apart in an ever-grow­ing im­muno-on­col­o­gy space that’s now seen sev­en PD-(L)1 drugs ap­proved by the FDA.

The biotech launched last No­vem­ber with $80 mil­lion in cash and has steadi­ly marched to­ward the clin­ic with its lead pro­gram. As Maren­go CEO Zhen Su pre­vi­ous­ly told End­points News, its I/O ap­proach can be com­pared to a car: If PD-(L)1 drugs are akin to re­leas­ing the im­mune sys­tem’s brakes, then Maren­go’s ap­proach tur­bocharges the en­gine.

Maren­go hopes to file an IND for its lead can­di­date, known as STAR0602, be­fore the year is out.

TCR ther­a­pies have been all the rage in the I/O space, par­tic­u­lar­ly af­ter Im­muno­core nabbed the first-ever TCR ap­proval ear­li­er this year. And as Adap­ti­m­mune pre­pares to sub­mit its own FDA pitch, more VCs are start­ing to take a clos­er look: In April, RA Cap­i­tal, Jeito and Omega all backed a $76 mil­lion Se­ries A for a lit­tle-known Swiss biotech called CDR-Life.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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